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Analytical Development for GMP Viral Vector Production – Establishing GMP Comparability and Minimizing Variability
Establishing comparability in viral vector production is essential for ensuring quality, safety, and efficacy under Good Manufacturing Practices (GMP). Process changes—such as scale-up, new equipment, or production site shifts—can impact manufacturing, making comparability studies crucial to demonstrating that modified products remain highly similar to the original.
Comparability relies on Critical Quality Attributes (CQAs) and requires carefully chosen analytical methods to ensure consistency across different development phases and manufacturing sites. Since R&D assays often differ from those used in GMP production, transitioning between them requires validated comparability. Anticipating future scale-up and selecting adaptable assays early can simplify this process, though premature assay development may become obsolete if the product undergoes multiple changes before GMP production.